Initiation Meeting of FDA-FE Clinical Study of Vicagrel Capsules

　　On August 18, the kick-off meeting of the FDA-FE clinical study of Vicagrel Capsules, a Class I new drug of Jiangsu Vcare Pharmatech Co., Ltd. (Jaingsu Vcare), was held at the Phase I Clinical Research Center of the First Hospital of Jilin University. This marks the official launch of the FDA clinical study of Vicagrel in the United States and the supporting Phase III clinical study in China.

　　Vicagrel plans to apply for marketing authorization in the United States following the 505(b)(2) pathway and improve the development efficiency through two key clinical pharmacological studies. As a Class I anti-thrombotic new drug, through the ingenious design of the drug structure, the in-vivo active metabolite of Vicagrel is the same as that of Clopidogrel. It breaks through and avoids the metabolic pathway of Clopidogrel, completes the key metabolic activation steps with the help of esterase, retains the safe and effective advantages of Clopidogrel, is expected to overcome the major defect of "Clopidogrel resistance", avoid the adverse reactions such as the high bleeding risk of Ticagrelor (especially for the elderly population taking the drug), and solve the problems of common combined medication with drugs like Repaglinide and Proton Pump Inhibitors. More notably, the equivalent dose of Vicagrel is only one-fifteenth of that of Clopidogrel, which means that the dose-related side effects are greatly reduced, and it is a potential new anti-platelet drug that meets the urgent clinical needs.

　　Liu Yongqiang, Chairman of Jaingsu Vcare, Gong Yanchun, General Manager, Lai Xiaojuan, Director of the Clinical Center, etc. participated in the meeting via remote video together with Ding Yanhua, Director of the Phase I Clinical Research Center of the First Hospital of Jilin University, and other researchers.

　　Director Ding Yanhua said, "We are very glad to cooperate with Jaingsu Vcare again in the clinical development of Vicagrel. The previous research results suggest that Vicagrel is a very promising new anti-thrombotic drug. We have great confidence in the clinical study of Vicagrel and look forward to the exciting trial results."

　　Chairman Liu Yongqiang delivered a speech: "Jaingsu Vcare focuses on the research, development and production of better pharmaceutical products for patients. Vicagrel is a differentiated innovative drug developed to meet the unmet clinical needs, and there is an urgent clinical demand for it. The Phase I Clinical Research Center of the First Hospital of Jilin University is a well-known domestic Phase I clinical research base, with a high-level research team and rich project experience. We would like to thank the center for its strong support in project scheduling. We hope that under the leadership of Director Ding, we can complete the relevant research with high quality as planned, help Vicagrel obtain approval for marketing as soon as possible, and enable more patients with cardiovascular and cerebrovascular diseases to use good and reliable drugs as soon as possible."

　　About the Phase I Clinical Research Center of the First Hospital of Jilin University

　　The Phase I Clinical Research Center of the First Hospital of Jilin University is a professional early-stage clinical trial platform for new drugs. It was established in 2011. The ward currently has 55 employees and 114 beds. Over the past 10 years, the center has undertaken 326 Phase I clinical trials of drugs, including 170 Phase I clinical trials of new drugs and 156 bioequivalence and biosimilar drug comparison trials. It is the Phase I center that has undertaken and completed the most clinical trials of innovative drugs in China.

　　The center attaches great importance to the protocol design and result analysis of early-stage clinical trials of innovative drugs, and uses model simulation technology combined with pre-clinical and human trial PK/PD data to predict the effective dose of drugs. It especially attaches importance to the Ia/IIb clinical trials with patients as subjects, and has a fast enrollment speed. It can achieve seamless connection from trials on healthy people to trials on patients, and enter Phase II and Phase III clinical trials as soon as possible. It is proficient in bioequivalence trials with high difficulty such as dual filings in China and the United States and high variability, and can complete the design of Chinese and English protocols and the writing of summary reports.

　　The center passed the FDA project inspection in 2015 without any deficiencies and has passed 48 inspections by the National Medical Products Administration. It has cooperated with more than a hundred domestic and foreign pharmaceutical companies and has become a professional Phase I clinical trial research center of international level.

　　About Vicagrel

　　Vicagrel is an industry-university-research cooperation project between Jaingsu Vcare and China Pharmaceutical University, and the company owns all the rights and interests of the project. Some of the preliminary work of the project was fully published in the Journal of Medicinal Chemistry under the American Chemical Society, and was highlighted and recommended by the journal SciBX under Nature.